MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 60MM; HIP ACETABULAR CUP

Model Number 1217-22-060

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erosion (1750); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Aug 7, 2017: litigation records received.Litigation alleges friction and wear between cobalt-chromium head and liner caused large amounts of toxic metal ions, pain, discomfort and inflammation.Update nov 30, 2017: pfs and medical records received.After review of medical records for mdr reportability, patient was revised to address chronic infection.Revision notes reported of gross purulence and some brown fluid in the hip joint with significant amount of infected, appearing synovium around the hip joint.There was erosion of the superolateral acetabulum and bone loss proximally around the femoral component as well as the superior aspect of the acetabulum, which appeared to be due to infection.Clinical notes reported of pain, fever and walking difficulty.Laboratory result for cobalt metal ions was above 7ppb.Patients wbc, sedimentation rate and c reactive protein are above normal.Updated product and lot information.Added cup to the complaint.This complaint was updated on: dec 14, 2017.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: null, device history batch: null, device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: aug 7, 2017: litigation records received.Litigation alleges friction and wear between cobalt-chromium head and liner caused large amounts of toxic metal ions, pain, discomfort and inflammation.Update nov 30, 2017: pfs and medical records received.After review of medical records for mdr reportability it was reported that the patient was revised to address chronic infection, extreme worsening pain, walking difficulty and unable to weight bear.Revision note stated, was gross purulence and some brown fluid in the hip joint with significant amount of infected, appearing synovium around the hip joint.There was bone loss proximally around the femoral component as well as the superior aspect of the acetabulum, which appeared to be due to infection.Distally the stem was very well fixed all the way to the tip of the stem.A greater trochanteric osteotomy was necessary to remove the stem.Blood test for cobalt and chromium are above 7ppb.Patients wbc, sedimentation rate and c reactive protein are above normal.Updated product and lot information.Added the cup product.This complaint was updated on: dec 14, 2017.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 60MM
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7152071
• MDR Text Key: 95959748
• Report Number: 1818910-2017-29787
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009863
• UDI-Public: 10603295009863
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1217-22-060
• Device Catalogue Number: 121722060
• Device Lot Number: CF6DY1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 144